CTMS and eTMF: Six Tips for Achieving Value from Integration

July 12, 2017

  • eTMF Resources

 CTMS and eTMF are two critical elements of an eClinical platform.  Most sponsors and CROs consider them a critical part of their infrastructure, and hope that they can be integrated to provide a seamless flow of information and documents between them. Recently there has been a lot of publicity about combining eTMF and CTMS into a single platform.  This sounds like an attractive solution, but consider the following issues:

  • Many organizations already have a CTMS or eTMF in production, and replacing it just to be on a single platform is often not a cost effective solution.
  • What’s really important is how the integration drives efficiency and compliance, not how it’s implemented.  A single solution that does not harmonize important data between the two elements will not provide significant value (nor will an inadequate integration between multiple solutions).

In the RFPs and RFIs we receive, we often see a question such as “Does your eTMF integration with CTMS?” Almost anyone responding will answer that question with Yes.  Instead, we suggest that you ask a question such as “Explain how your eTMF-CTMS integration drives consistency, efficiency and compliance.  Provide a specific list of integration points, data exchanged, and what the data is used for.”

Below are Wingspan’s recommendation for achieving the most value from CTMS integration for eTMF:

1. Use the integration to drive consistency.  By synchronizing study and site names, your organization will have a consistent view of the trial structure, and avoid delays or missing information when sites are added to a study that is already ongoing.

2. Use the integration to provide awareness of documents that are needed in eTMF.  By including details of the investigators and sub-investigators in the integration, you should be able to trigger the generation of placeholders for their documents in eTMF.  As a result, you will not have to manually track investigators in eTMF or respond to new sub-investigators or changes in principal investigators. This in turn will prevent non-compliance resulting from missing or delayed reporting of investigators to the FDA, as required in the CFR: “The sponsor shall notify FDA of the new investigator within 30 days of the investigator being added.”

3. Use the integration to ensure that monitoring visit documents are planned and collected.  A common inspection finding by Health Authorities is that monitoring documents are missing from the TMF.  You should be able to use your monitoring visit schedule from CTMS to create placeholders in eTMF for the monitoring documents you require (Monitoring Visit Report, follow-up letter, etc.)  Furthermore, when visits are added or dates changed, the system should automatically update these placeholders.

4. Determine how often data needs to be uploaded from CTMS.  Depending on how many trials you are running and how quickly conditions are changing, you might need to bring information in hourly, daily or weekly.  In addition, you will need to decide if your data upload process is manual or automated.

5. Focus on data first and documents afterwards.    Once the upload of data from CTMS is functioning smoothly, consider synchronizing documents from CTMS as well.  Most commonly, this integration will focus on Monitoring Visit Reports.  It should be possible to bring these into eTMF as properly filed, final documents.

6. Have a plan for correcting erroneous CTMS data.  It’s not uncommon for CTMS data to require corrections, such as change in site ID or name, replacement of temporarily site ID, or correction of PI name.  We have even seen instances where a site was assigned to the wrong country.  You should have a plan in place for correcting common errors, including an understanding of what you can correct yourselves and what you will need your vendor to correct.  It’s important to ensure that you don’t end up with bad data that cannot be corrected.

Using these guidelines, you can evaluate the value of the integration to your organization.

You will also want to understand what the investment is to achieve this value, of course – here the questions are:

  • Can these systems be integrated by configuration or custom development?  What is the effort, and is it dependent on (for example) which CTMS is used?
  • Who can implement the integration – you, the vendor, a third party?

An experienced vendor should normally be able to provide a fixed price quote for integration based on documented assumptions.